(19 days)
The BioMedix PADnet Lab is a non invasive device used to record physiological data from the lower extremity arterial system using pulse volume recordings and oscillometric segmental systolic blood pressures for use by the Physician in the identification of vascular pathology. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for use on or near non intact skin.
The BioMedix PADnet Lab is a non invasive cardiovascular blood flow monitor. It is intended for use in the early detection of peripheral vascular disease. The BioMedix PADnet Lab is a non invasive cardiovascular blood flow monitor. It is intended for use by trained medical professionals in a hospital or clinic. It is not to be operated in an explosive atmosphere nor in the proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the PADnet Lab. The BioMedix PADnet Lab is a Prescription Device, not life supporting or life sustaining, not an implant, supplied non-sterile with pressure cuffs. It requires a Personal Computer with the following requirements: Windows 2000 Operating System or higher, 128 MB RAM, 20 GB Free Hard Disk Space, 600 MHz Processor or higher.
The provided document is a 510(k) premarket notification for the BioMedix PADnet Lab, which aims to demonstrate substantial equivalence to a predicate device, the Flostat Vascular Lab. This type of submission focuses on comparing the new device's characteristics and intended use to an already legally marketed device, rather than providing extensive clinical study data a standalone performance device. The document primarily highlights similarities and differences between the new device and the predicate device, emphasizing that the PADnet Lab's differences do not raise new safety or effectiveness concerns.
Therefore, many of the requested criteria, particularly those pertaining to acceptance criteria with reported performance, detailed study design, ground truth establishment, a human-in-the-loop study, or a multi-reader multi-case study are not typically part of a 510(k) submission for this type of device. The acceptance criteria in this context are primarily about demonstrating equivalence to the predicate device in terms of technology, safety standards compliance, and intended use.
Here's the information that can be extracted from the provided document:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this 510(k) are implicitly based on demonstrating substantial equivalence to the predicate device (Flostat Vascular Lab) in various technical and operational aspects, and adherence to relevant safety standards. The document doesn't present a table of numerical performance targets with corresponding measured values for the PADnet Lab's diagnostic capabilities. Instead, it compares features.
| Acceptance Criterion (Implicitly based on Predicate Device & Standards) | Reported Device Performance (PADnet Lab) |
|---|---|
| Intended Use | Same intended use: Non-invasive assessment of the lower extremity arterial system using pulse volume recordings and oscillometric segmental systolic blood pressures to assist in the identification of vascular disease. |
| Pulse Volume Recording Mechanism | Plethysmograph (Same as predicate) |
| Segmental Pressure Flow Sensor | Oscillometric (Different from predicate's distal flow sensor, but deemed not to raise new safety/effectiveness concerns) |
| Patient Population | Male/Female Adult (Same as predicate) |
| Environment of Use | Hospital or Clinic (Same as predicate) |
| Power Source | AC converted to DC (Same as predicate) |
| Software Controls | Operator initiated (Same as predicate) |
| Cuff Deflation Rate | 3-5 mm Hg/Sec (Same as predicate) |
| Operating Environment | 0 to +40°C, 15-90% humidity (Same as predicate) |
| Storage Environment | -40 to +50°C, 5-95% humidity (Same as predicate) |
| Safety Standards Compliance | Yes (Tested to EN60601-1 Electrical Safety, ISO 10993-1 Biological evaluation) |
| EMC Compliance | Yes (Tested to EN60601-1-2 EMC) |
| Prescription Device | Yes (Same as predicate) |
| Cuff Bladder Deflation | Automatic (Same as predicate) |
| Inflation Method | Automatic (Same as predicate) |
| Cuff Sizes | Multiple (Same as predicate) |
| Clinical Reports Generated | Yes (Same as predicate) |
| Printed Reports Generated | Yes (Same as predicate) |
| Sterility | Supplied Non-Sterile (Same as predicate) |
| Physical Characteristics (Weight, Size, Data Acquisition) | PADnet Lab is lighter, smaller, and uses single-site data acquisition (Differences noted but argued not to affect substantial equivalence). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail a specific "test set" in the context of clinical performance evaluation studies for the PADnet Lab. The submission is a 510(k) for substantial equivalence based on technical and functional comparison to a predicate device, along with adherence to recognized safety and EMC standards. Clinical data (e.g., from a test set of patients) for this specific device's diagnostic performance is not provided as the primary method to demonstrate substantial equivalence in this filing. The term "Clinical Reports" under the comparison table refers to the device's ability to generate such reports, not the submission of clinical study data for FDA review.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical test set with ground truth established by experts is described in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set and adjudication method are described in this 510(k) submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a "Blood Flow Monitor" and a "Plethysmograph", likely providing physiological measurements rather than interpretive "AI assistance" to human readers. No MRMC or human-in-the-loop study is mentioned.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. The PADnet Lab is a measurement device, not an "algorithm-only" or AI-driven diagnostic system in the sense of an imaging analysis tool. Its performance is based on the accuracy of its physiological measurements, for which a specific standalone performance study is not detailed here beyond compliance with general electrical and biological safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is specified as no clinical performance study for diagnostic accuracy is detailed in this 510(k). The basis for "ground truth" in this context would implicitly be the validated performance of the predicate device and the accepted physiological principles behind plethysmography and oscillometric measurements.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device requiring such.
9. How the ground truth for the training set was established
Not applicable. No training set is discussed.
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).